(77 days)
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No
The description focuses on the physical properties and intended use of a traditional dental impression material, with no mention of AI or ML.
No
The device is an impression material used to create a model for dental work, not to treat a condition or disease.
No
The device is described as a dental impression material used for creating a physical copy (gypsum cast) of the oral cavity, not for diagnosing conditions or diseases.
No
The device description clearly states it is a dental impression material based on alginate, which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to take impressions of the oral cavity for the purpose of constructing a gypsum cast. This is a physical process used to create a model of the patient's mouth.
- Lack of Diagnostic Purpose: The description does not mention any diagnostic purpose. It is not used to analyze samples from the body (like blood, urine, or tissue) to provide information about a patient's health status, disease, or condition.
- Physical Material: The device is a physical material (alginate powder) used to create a physical mold.
IVDs are typically used to perform tests on biological samples to aid in diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
ImprEssix alginate impression material is a dental impression material based on alginate. It is used for taking impressions of the oral cavity with the purpose of constructing a gypsum cast that is a copy of the situation in the mouth. ImprEssix has an extra fast setting time, high elasticity, high tear resistance, can be poured twice with gypsum and is presented in a attractive fuchsia-coloured powder with a red-fruit flavour. Therefore, ImprEssix is particularly suited for orthodontics
Product codes
ELW
Device Description
ImprEssix alginate impression material is a dental impression material based on alginate. It is used for taking impressions of the oral cavity with the purpose of constructing a gypsum cast that is a copy of the situation in the mouth. ImprEssix has an extra fast setting time, high elasticity, high tear resistance, can be poured twice with gypsum and is presented in a attractive fuchsia-coloured powder with a red-fruit flavour.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
oral cavity
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 872.3660 Impression material.
(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
NOV 2 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Richard Woortman Manager Technical Services Cavex Holland B.V. Harmenjansweg 21 Haarlem, 2031WH NETHERLANDS
Re: K052455
Trade/Device Name: ImprEssix Alginate Impression Material Regulation Number: 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: August 15, 2005 Received: September 7, 2005
Dear Mr. Woortman:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Woortman
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k) NUMBER (IF KNOWN): KO 52455
DEVICE NAME: ImprEssix
Alginate impression material
INDICATIONS FOR USE:
ImprEssix alginate impression material is a dental impression material based on alginate. It is used for taking impressions of the oral cavity with the purpose of constructing a gypsum cast that is a copy of the situation in the mouth. ImprEssix has an extra fast setting time, high elasticity, high tear resistance, can be poured twice with gypsum and is presented in a attractive fuchsia-coloured powder with a red-fruit flavour. Therefore, ImprEssix is particularly suited for orthodontics
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED. )
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use -(Per 21 CFR 801.109) OR
Over-The-Counter-Use (Optional Format 1-2-96)
Susan Rumm
ා 3 (Sign-Off) of Anesthesiology, General Hospital, tion Control, Dental
Number. RO